Numerous GMP Deficiencies at OTC Manufacturer in Puerto Rico

The USA FDA has issued a Warning Letter to a pharmaceutical manufacturer for failing to adequately address numerous deficiencies identified during an inspection. The inspection at the site in Puerto Rico had already taken place in October/November 2021. The FDA had notified the manufacturer of the GMP deficiencies by the Form 483. The FDA considered the manufacturer's response and the measures taken to be insufficient, so that a Warning Letter now followed. At the site OTC products such as wound disinfectants for open wounds and hand disinfectants for healthcare personnel are manufactured.

Numerous deficiencies concern the manufacturer's quality system. For example, both the input materials and the pharmaceutical end products are not adequately tested for identity, purity, etc. The lack of quality control is also serious. The lack of process validation, as well as the insufficient description of deviation investigations, equipment cleaning and change management, must of course also be assessed as serious. Compliance with the stability programme and the annual product review (APR) were also criticised.

The condition of the facility also gave cause for complaint. Broken walls, dirt and water near open product were found.

Further, the water system was criticised. It was neither of a suitable design nor in a valid condition that would guarantee the production of the required purified water (USP).

Although the manufacturer in Puerto Rico had already hired a consultant to correct the deficiencies described in the Form 483, the manufacturer now faces numerous action items. FDA expects, among other things:

• Ensure quality oversight throughout the plant 
• Establishment of a CAPA system to ensure timely identification of equipment & utilities problems, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades of equipment and infrastructure 
• A detailed validation programme 
• A timetable for the implementation of product validations 
• The qualification of the equipment 
• An assessment of the water system in terms of design, control, maintenance 
• A thorough remediation plan for the water system installation 
• A risk analysis for all product batches in the US market that could pose a risk due to the problems in the water system

Please alsoe see the complete Warning Letter to the manufacturer in Puerto Rico for further details.